Multi-drug resistant tuberculosis (MDR-TB)

About para-aminosalicylic acid in gastro-resistant granules

Para-aminosalicylic acid is used for the treatment of MDR-TB, as part of an appropriate combination regimen, in adults and paediatric patients from 28 days of age and older, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The product contains para-aminosalicylic acid formulated in gastro resistant coated granules. The gastro resistant formulation prevents formation of a hepatotoxic substance; meta-aminophenol, which is otherwise formed upon contact of para-amino salicylic acid with the acid environment in the ventricle. The product is usually dosed three times per day and is provided in convenient sachets, which contain a typical dose for adults. For children or patients requiring different dosage, a validated dosing spoon has been developed to facilitate and secure administration of the correct dose. The product is approved in the US under the trade-name Paser® and is currently used in Europe on a named patient basis. The positive opinion issued by the CHMP on November 21, 2013, is the concluding step of the European Medicinal Agencies review of the application for EU marketing authorization. The application will now be sent to the European Commission for formal approval of marketing authorization, which is normally expected within 60 days. The product has an orphan drug designation which, following marketing authorization, will render the product at least ten years of market exclusivity within the EU

About Orphan Drug Designation

The EU orphan drug legislation was adopted in the year 2000 with the goal of stimulating development of pharmaceuticals for rare conditions with unmet medical needs, so called orphan drugs. A rare condition is defined as a condition affecting less than 5 out of 10 000 individuals across the EU. Under the legislation, companies developing such pharmaceuticals may apply for an orphan drug designation of their product, which makes it eligible for several incentives, including free assistance, fee reductions and waivers throughout the development and, following marketing authorization, ten years market exclusivity.

About Lucane Pharma

Lucane Pharma is a privately owned pharmaceutical company, Paris based, set up end 2009. Lucane Pharma develops and or inlicenses, registers and commercializes medicinal products for rare conditions. Since its inception, Lucane Pharma has already obtained the EU registration for its first developmenet product Pheburane. A positive opinion has recently been obtained from EMA for p amino salicylic acid, for Multi Drug resistant Tuberculosis. Several other developments are currently ongoing in the metabolic disorders area as well as in the Tuberculosis area.

Medical Need today announced that it has entered into an exclusive supply and distribution agreement with French company Lucane Pharma, relating to a product containing para-aminosalicylic acid (PAS) in a gastro resistant coated granular formulation. PAS is used in the treatment of multi-drug resistant tuberculosis (MDR-TB) in combination with other anti-tuberculosis agents. The gastro-resistant formulation is important, as it prevents formation of a toxic metabolite in the acidic environment of the gut. In Europe it has orphan drug designation, which following approval will render at least ten years of market exclusivity within the EU.

The product is already approved in the US under the trade-name Paser®, and is currently undergoing the final steps of regulatory review in the EU. The scientific committee of the European Medicines Agency, the CHMP, last week adopted a positive opinion, recommending the granting of EU marketing authorization for the product. The application will now be sent to the European Commission for formal approval, which is typically expected within sixty days.

Under the agreement, Medical Need has the exclusive rights to the product in Denmark, Finland, Iceland, Norway and Sweden, and will be responsible for the distribution, marketing and sale in this territory.

“Multi-drug resistant tuberculosis is a major threat to public health globally, and is a growing problem also in the Nordic countries. This is one of the important pharmaceuticals used to cure this severe disease, to prevent further development of resistance among tuberculosis bacteria and spread of tuberculosis in the society”, said Kennet Rooth, COO of Medical Need, and continued: “We are very happy to extend our existing partnership with Lucane Pharma with the addition of this orphan drug to our product portfolio.”

About Multi-Drug Resistant Tuberculosis (MDR-TB)

Tuberculosis is a severe and potentially lethal bacterial infection caused by Mycobacterium Tuberculosis. It primarily affects the lungs, but may also affect other parts of the body. While Tuberculosis was previously decreasing in the western world over the course of the last century, it has during the past decades started to increase again. Globally, tuberculosis is a significant problem and is the type of bacterial infection responsible for the highest number of deaths in adults. Individuals with impaired immune system are particularly susceptible to infection, why there is a large co-morbidity in patients affected by HIV. Globally it is estimated that approximately 8 million people will develop active disease on a yearly basis and 1.7 million will die from the disease every year.

Multi-drug resistant tuberculosis (MDR-TB) is defined as infection by a strain of mycobacterium tuberculosis, resistant to at least two of the first-line anti-tuberculosis medications. It complicates and limits the possibility to cure the affected individuals and to prevent spread of the disease in the society. Like for other bacteria, resistance develops when the levels of antibiotics in the affected patients are insufficient to kill all the bacteria, which may be caused by poor compliance to the treatment regimen for example due to lack of medication or funding. In recent years, bacterial strains with very broad resistance pattern to many antibiotics (extensively drug resistant (XDR-TB)) have started to emerge and are of particular concern. XDR-TB currently accounts for approximately 10% of MDR-TB world-wide.

MDR-TB should be treated with a combination of several anti-tuberculosis medications, often up to five different substances and usually for a period of up to two years, in order to secure complete eradication of the bacteria and prevent further development of resistance. Left untreated, MDR-TB has a mortality rate of as high as 80%. MDR-TB is considered a major threat to global public health by the WHO, which currently estimates approximately 0.5 million new cases of MDR-TB are reported each year, the vast majority of which in the developing world. Over the past decade, MDR-TB has become an increasing problem also in the EU and the Nordic countries, partly linked to immigration.

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